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Impurity Level Confirmation by Nuclear Magnetic Resonance (NMR) Spectroscopy

NMR spectroscopy laboratory for pharmaceutical impurity level confirmation
CMC Strategy

Impurity Level Confirmation by Nuclear Magnetic Resonance (NMR) Spectroscopy

Two approaches for determining known process impurity levels in multiple batches of API.

Almac GroupBiotechnology Media Insights
Full White Paper Content

This case study discusses two approaches taken when clients required determination of known process impurities in multiple API batches, addressing technical challenges in impurity detection.

Why NMR

NMR provides structural information and quantification without requiring reference standards for every impurity.

Two Approaches

Differing client needs led to complementary strategies for batch analysis.

Technical Challenges

Signal overlap and sensitivity were managed through careful method design.

About This White Paper

This white paper is published by Almac Group and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.

Published by Almac Group · Curated by Biotechnology Media Insights

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